510(k) Report

510(k) · Cleared

Cleared

Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device

K080509510(k) TraditionalCleared May 5, 200870-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Cleared on May 5, 2008 as substantially equivalent to K013392 (Medtronic Vascular, 2002) and 1 other predicate after a 70-day review. Its family tree reaches back 9 generations to 1995. 10 later devices descend from it.

Decided
May 5, 2008
Review
70 days
Class
Class II
Product code
OCL
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K942299 (1995). 54 ancestors in all, the oldest K811390 (1981). 10 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 5 other ancestors2004: 1 other ancestor2001: 6 other ancestors1992: 2 other ancestors2003: 2 other ancestors1997: 7 other ancestors1987: 1 other ancestor2000: 4 other ancestors1999: 3 other ancestors1998: 5 other ancestors1995: 4 other ancestors1994: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestor2009: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant clearedK942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996×2: 2 generations cleared close together, K973686 (1997), K980110 (1998) K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K020919 · Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 · AtriCure, Inc. · 2002×2: 2 generations cleared close together, K022894 (2004), K040641 (2004) K043579 · Atricure Bipolar System · AtriCure, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 7 other ancestors3 generations back: 8 other ancestors4 generations back: 18 other ancestors5 generations back: 6 other ancestors6 generations back: 5 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K043579 · Atricure Bipolar System · AtriCure, Inc. · 2007K040641 · Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1 · Epicor Medical, Inc. · 2004K022894 · Epicor Medical Ablation System · Epicor Medical, Inc. · 2004K020919 · Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 · AtriCure, Inc. · 2002K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K980110 · Endocre Cryocare Cryosurgical System · Endocare, Inc. · 1998K973686 · Endocare Cryocare Cryosurgical System · Endocare, Inc. · 1997K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996K942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995−50
  1. Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 5 generations between
  3. 3 generations backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
  4. 2 generations backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
  5. 1 generation backK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
  6. This deviceK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
  7. Descendant · cites it directly · 3 of its ownK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
  8. Descendant · cites it directly · 2 of its ownK182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical…Medtronic · 2018
  9. Descendant · cites it directly · 2 of its ownK121767 Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc. · 2012 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK200514 Cardioblate Gemini-s Surgical Ablation DeviceMedtronic · 2020 · Recalled
  11. Descendant · 2 generations on · 1 of its ownK191601 Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · Recalled
Show all 9 generations
  1. Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
  3. 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
  4. 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
  5. 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  6. 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  7. 3 generations backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
  8. 2 generations backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
  9. 1 generation backK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
  10. This deviceK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 22018: 12019: 22020: 12022: 12024: 1
2009high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 10 · See all
  • K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc. · 2010 · cites it directly3descendants
  • K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic · 2018 · cites it directly2descendants
  • K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc. · 2012 · cites it directly2descendants
  • K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic · 2020 · 2 generations on1descendant
  • K191601Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K942299Endocare Cryotherapy SystemCytocare, Inc.1995—
−8K963826Endocare Crycare Cryosurgical SystemEndocare, Inc.1996—
−7K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc.1997—
−6K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc.1998—
−5K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
−4K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
−3K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—
−2K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9…Epicor Medical, Inc.2004—
−1K043579Atricure Bipolar SystemAtriCure, Inc.2007—
0 (this device)K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation…Medtronic, Inc.2008—
+1K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831…Medtronic, Inc.2010—
+1K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation…Medtronic2018—
+1K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.20121
+2K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic20201
+2K191601Valleylab FT10 Electrosurgical PlatformCovidien20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198710
198810
199110
199220
199410
199540
199610
199770
199850
199930
200040
200160
200250
200320
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201220
201810
201920
202010
202210
202410
FIG. 1 — Lineage of K080509, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OCL device

  1. #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…
Summary page 1
…Generator (K060400) and the following ablation devices: • Cardioblate® Monopolar Pens, Models 60813 and 60814 (K013392) * Cardioblate®'BP2 Surgical Ablation Device, Model 60831 (K060400)…
Medtronic Vascular20021
*K043579Atricure Bipolar System
Summary page 2
…e 2 === o Predicate Devices: Cardioblate® Monopolar Pen, Model 60813 and Model 60814 (KG13392), and AtriCure® Bipolar System (K043579). Predicate Device Intended Uses: "The Medtronic Cardioblate®System is intended to…
AtriCure, Inc.2007—

Also cleared against K013392: 11 other devices →

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103
K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182
K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.20122
K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091
K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
  • 3 of the 54 ancestors have a recall of any class.
  • Of its descendants, K093203 (Medtronic, Inc., 2010) has gone furthest, with 3 descendants of its own.
  • 11 other devices also cite its predicate K013392.

How does its category compare?

All OCL devices

OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OCL

1in 2025

2007: 32008: 52009: 22010: 22011: 22012: 62013: 22014: 12017: 12018: 22019: 62020: 12021: 22022: 22024: 12025: 1
2007high 6 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCL

85in 2019

2007: 139 days median2008: 81 days median2012: 75 days median2019: 85 days median
2007high 139 (2007) · low 75 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCL

1in 2021

2008: 12009: 12010: 22013: 12016: 12019: 42020: 42021: 1
2007high 4 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCL

46in 2025

2009: 82010: 232011: 212012: 212013: 132014: 152015: 312016: 762017: 552018: 612019: 492020: 372021: 632022: 592023: 992024: 592025: 46
2007high 99 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007313900
200858110
20092—18
20102—223
20112—021
2012675021
20132—113
20141—015
20150—031
20160—176
20171—055
20182—061
2019685449
20201—437
20212—163
20222—059
20230—099
20241—059
20251—046
20260—0—

What is it indicated for?

The Medtronic Cardioblate® System is intended to ablate cardiac tissue during general surgery using radiofrequency energy.

Indications for use as stated in the FDA summary.

Also cleared against K013392

11 other devices cite the same predicate.

  • K073605Atricure Coolrail Linear PenAtriCure, Inc. · 2008
  • K043579Atricure Bipolar SystemAtriCure, Inc. · 2007
  • K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular · 2007
  • K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 20061 recall
  • K050459Atricure Isolator Transpolar PenAtriCure, Inc. · 20051 recall

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

Recent decisions in OCL

The OCL category page

  • K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025
  • K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024
  • K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator®…AtriCure, Inc. · 2022
  • K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc. · 2022
  • K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021

https://510kreport.com/device/K080509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080509

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026